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Hospital Volume and Mortality After Transjugular Intrahepatic

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Hospital Volume and Mortality After Transjugular Intrahepatic Page 1 of 28 Hepatology 1 Title: Hospital volume and mortality after trans-jugular intrahepatic portosystemic shunt creation in the United States Short Title: Effect of hospital TIPS volume on mortality Authors: Ammar Sarwar 1, Lujia Zhou 1, Victor Novack 2, Elliot B. Tapper 3,4 , Michael Curry 3 Raza Malik 3, Muneeb Ahmed 1 1 Division of Vascular and Interventional Radiology, Department of Radiology, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA; AS: Assistant Professor, LZ: Research Fellow; MA: Associate Professor 2 Clinical Research Center, Soroka University Medical Center and Faculty of Health, Ben-Gurion University of the Negev, Beer-Sheva, Israel; VN: Professor and Head of Department 3 Division of Gastroenterology and Hepatology, Department of Medicine, Beth Israel Deaconess Medical Center/Harvard medical School, Boston, MA; MC: Associate Professor, RM: Assistant Professor 4 Division of Gastroenterology, Department of Medicine, University of Michigan Health System; EBT: Assistant Professor Key Words: volume-outcome relationship; mortality; TIPS; administrative data Author Manuscript This is the author manuscript accepted for publication and has undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of record. Please cite this article as doi:10.1002/hep.29354. This article is protected by copyright. All rights reserved. Hepatology Page 2 of 28 2 : Correspondence Ammar Sarwar, M.D. Department of Radiology, WCC 308-B Beth Israel Deaconess Medical Center 1 Deaconess Road, Boston, MA02215 Phone: 617-754-2523 Fax: 617-754-2545 E-mail: [email protected] Abbreviations: AHRQ: Agency for Healthcare Research and Quality ANOVA: Analysis of Variance APR-DRGs: All Patient Refined Diagnosis Related Groups EVAR: Endovascular Aortic Repair HCUP: Healthcare Cost and Utilization Project HE: hepatic encephalopathy HRS: hepatorenal syndrome ICD-9: International Classification of Diseases version 9 ICU: Intensive Care Unit MELD: Model of End-stage Liver Disease NAFLD: non-alcoholic fatty liver disease NIS: Nationwide Inpatient Sample NRD: Nationwide Readmission Database SBP: Spontaneous bacterial peritonitis SID: State Inpatient Database TIPS: Transjugular intrahepatic portosystemic shunt placement Grant Support: None.Author Manuscript Disclosures: None of the authors have conflicts of interest relevant to this manuscript. Hepatology This article is protected by copyright. All rights reserved. Page 3 of 28 Hepatology 3 ABSTRACT The link between higher procedure volume and better outcomes for surgical procedures is well established. We aimed to determine if procedure volume affected inpatient mortality in patients undergoing transjugular intra-hepatic portosystemic shunt (TIPS). An epidemiological analysis of an all-payer database recording hospitalizations during 2013 in the United States (Nationwide Readmissions Database) was performed. All patients’ ≥18 years old undergoing TIPS during a hospital admission (n=5529) without concurrent or prior liver transplantation were selected. All-cause inpatient mortality was assessed. Risk-adjusted mortality was assessed for hospitals categorized into quintiles based on annual TIPS volume; very low (1-4/year), low (5- 9/year), medium (10-19/year), high (20-29/year), and very high (≥30/year). TIPS were placed in 5529 patients (57±10.9 years; 37.5% female). Mortality decreased with rising annual TIPS volume (13% for very low to 6% for very high volume hospitals; p<0.01). Elective admissions were more common in hospitals with higher annual TIPS volume (20.3% for very low to 30.8% for very high; p<0.01). On multivariate analysis, compared to hospitals performing ≥30 TIPS per year, only hospitals performing 1-4/year (aOR: 1.9, 95%CI:1.21-3.01; p=0.01), 5-9/year (aOR: 2.0, 95%CI:1.25-3.17; p<0.01), and 10-19/year (aOR: 1.9, 95%CI:1.17-3.00; p=0.01) had higher inpatient mortality (20-29/year [aOR: 1.4, 95%CI:0.84-2.84; p=0.19]). The absolute difference between risk-adjusted mortality rate for very low volume and very high volume hospitals was 6.1% (13.9% vs. 7.8%). TIPS volume of ≤20 TIPS/year, variceal bleeding, and nosocomial infections were independent risk Conclusions: factors for inpatient mortality in patients with both elective and emergent admissions. The risk of inpatient mortality is lower in hospitals performing ≥20 TIPS per year. Future research exploring preventable factors for higher mortality and benefits of patient transfer to higher volume centers is warranted. Author Manuscript Hepatology This article is protected by copyright. All rights reserved. Hepatology Page 4 of 28 4 The association between hospitals with higher annual procedure volume and improved survival has been demonstrated for most major surgical procedures.(1–4) Better patient outcomes at higher volume centers have also been reported for percutaneous cardiovascular interventions, such as coronary and valvular procedures, peripheral arterial interventions, and endovascular abdominal aortic aneurysm repair (EVAR).(5–10) Building on these findings, several studies have shown that increasing referral of elective EVAR cases to high-volume centers by a process known as regionalization leads to improved patient outcomes.(11–14) However, such study has not yet been expanded to percutaneous procedures in non-cardiovascular patients, where interventional procedures can be complex, associated with an operator learning curve, and are performed in critically-ill patients. Transjugular intrahepatic portosystemic shunt (TIPS) placement for treating sequalae of portal hypertension requires a high degree of technical and clinical experience to achieve optimal patient outcomes.(15,16) A recent study of the Nationwide Inpatient Sample (NIS) reported a reduction in inpatient mortality during admissions with TIPS placement from 12.5% in 2003 to 10.6% in 2012.(17) Studies have demonstrated that variation in inpatient mortality for patients with cirrhosis can be a result of hospital-level factors.(18) The annual hospital volume of admissions for patients with cirrhosis or esophageal variceal bleeding alone does not account for variations observed in inpatient mortality, although patients at high volume hospitals with these conditions were more likely to undergo TIPS placement, suggesting that additional study on the influence of TIPS volume on inpatient outcomes is likely warranted.(18,19) Given the known variations in mortality for patients with cirrhosis and relationship between annual procedure volume and inpatient mortality for image-guided procedures, we sought to identify pre-procedure patient, hospital and volume characteristics that may explain variations in mortality after TIPS procedures. Author Manuscript Hepatology This article is protected by copyright. All rights reserved. Page 5 of 28 Hepatology 5 METHODS Data Source: The National Readmission Database (NRD) is a database developed by the Healthcare Cost and Utilization Project (HCUP) that includes all hospitalizations during 2013 in 21 geographically diverse states.(20) This all payer (insured and uninsured) database contains data from approximately 14 million discharges, representing 49.1% of all US hospitalizations. It records de-identified patient and hospital demographics, discharge diagnoses, inpatient procedures, length of stay, and discharge status. In addition, it includes 29 Elixhauser co-morbidity measures that are assigned using the Agency for Healthcare Research and Quality (AHRQ) comorbidity software.(21) These measures identify co-existing medical conditions not directly related to the principal diagnosis and likely to have originated prior to the hospital stay. It also includes All Patient Refined Diagnosis Related Groups (APR-DRGs) severity measures assigned using software developed by 3M Health Information Systems to adjust for case-mix severity. The APR-DRG risk of mortality score has been validated as the most discriminative and predictive mortality risk score for cirrhotic patients in the NIS, a smaller HCUP database (20% sample, 7.8 million annual discharges).(22) In contrast to the NIS, the NRD links all hospitalizations for each patient allowing analysis at a patient rather than discharge level and providing the ability to control for multiple hospitalizations with a TIPS procedure code for the same patient. To ensure generalizability, discharge weights were developed in the NRD to produce national estimates after the data were stratified, by patient and hospital characteristics. National estimates were calculated by applying discharge weights prior to analysis. The study was reviewed by the institutional review board as appropriate for exemption from institutional review board oversight because no protected health information was available in the data. Study population: Procedure diagnosis codes for all hospitalizations in the database were searched for TIPS procedures. Inclusion criteria were International Classification of Diseases 9 th version (ICD-9) procedure code 39.1 (Intra-abdominalAuthor Manuscript venous shunt), and age ≥18 years. Since placement of multiple TIPS in a single patient is rare, patients with multiple ICD-9 codes of 39.1 (n=58) were excluded. Liver transplantation changes outcomes for cirrhotic patients, therefore patients with ICD-9 procedure code 50.5* (liver transplantation) Hepatology This article is protected by copyright. All rights reserved. Hepatology Page 6 of
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